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Port-a-cath and Hickman line devices for chemotherapy delivery

Port-a-cath and Hickman line devices for chemotherapy delivery: A randomised phase II study and pre-trial economic model development to inform the design of a subsequent randomised phase III controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79422566
Enrollment
100
Registered
2013-03-06
Start date
2011-08-09
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chemotherapy, device study Cancer Malignant neoplasm, unspecified

Interventions

Patients will be randomised in a 3:1 ratio to receive either a Hickman line (n=75) or a Port-a-cath (n=25). Patients participating in the study will be asked to complete quality of li
a further questionnaire will be completed at the time of planned line removal. Patients will be seen as per standard of care for their treatment. Complication forms will be completed

Sponsors

NHS Greater Glasgow and Clyde (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Oncology patients with solid tumours who are scheduled for access line insertion 2. Patients must be willing and clinically able to receive either a Hickman line or a Port-a-cath 3. Patient must provide informed consent 4. Age =18 years, male and female 5. Able to comply with study protocol

Exclusion criteria

Exclusion criteria: 1. Any evidence of any medical or psychiatric disorders that would be a contra indication to study participation 2. Life expectancy < 3 months

Design outcomes

Primary

MeasureTime frame
Cost effectiveness of Ports

Secondary

MeasureTime frame
Complication data including line infection (with and without antibiotics), tract infection, (with/without antibiotics), occlusion, migration, loss of line, central vein thrombosis, exit site haematoma, and skin breakdown will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator. Reinterventions including line replacement, thrombolysis, stripping and manipulations will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026